Formulation And Development ROW DM OSD Nagpur Plant

Select Source International

10 - 20 years

8 - 14 Lacs

nagpur

Posted:1 day ago| Platform:

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Skills Required

process development f&d formulation development row qbd process improvement technology transfer research and development

Work Mode

Work from Office

Job Type

Full Time

Job Description

Planning and coordinating with project management team, regulatory affairs, analytical development and management team

Pivotal involvement in product pre-formulation study and prototype formulation development
Preparing reports, compiling/interpreting data and validating stability data of developmental batches
Key role involvement in a vast gamut of activities encompassing - formula & process optimization, monitoring scale-up batches, validating batches for regulatory markets; adhering to regulatory markets like ROW standards and so on
Responsible for executing site transfer projects from contracts like Bells, Teva, Relonchem and Nova
Involved in evaluating Critical Quality Attribute (CQA) & Critical Process Parameter (CPP) of the product during technology transfer while in a process challenge study
Preparing a wide range of reports such as Interim Pre-formulation summary reports, formulation development reports and product development reports as per exhibit batch records
Instrumental in Master Formula Record (MFR), Process Validation Protocol (PVP), Batch Manufacturing Record (BMR), Hold Time Study Protocols, Sampling Protocols, Compatibility Study Protocols and Stability Protocols
Executing DOE (Stat-Ease) trials by QBD concept and designing the process as given
Extensively preparing and reviewing Batch Production Control Records (BPCR) for ANDA submission & commercial purposes

if interested mail cv at :- neetij@selectsourceintl.com

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